US FDA Accepts GSK RSV Vaccine Application for Younger Adults

GSK plc announced on July 14 that the US Food and Drug Administration (FDA) has accepted an application to review an expanded indication for its respiratory syncytial virus (RSV) vaccine, Arexvy. The application seeks to make the vaccine available to adults aged 18-49 who are at increased risk of developing lower respiratory tract disease (LRTD) caused by RSV.

RSV is a common contagious virus that affects the lungs and breathing passages. In the US, an estimated 21 million adults under the age of 50 have at least one diagnosed risk factor for severe RSV infection. These risk factors include conditions such as chronic obstructive pulmonary disease (COPD), asthma, and heart failure.

The regulatory submission is supported by positive Phase IIIb trial data, which evaluated the immune response and safety of the vaccine in the 18-49 age group at increased risk. The observed safety and reactogenicity data were consistent with the results from the Phase III program that supported the vaccine's initial approval.

The FDA is expected to make a regulatory decision on this submission in the first half of 2026. GSK's Arexvy is currently approved in the US for the prevention of RSV-LRTD in adults aged 60 and older, and in those aged 50-59 who are at increased risk. The company is also seeking expanded indications for its RSV vaccine in other geographies, including the European Economic Area and Japan.